Standard Operating Procedure for Equipment Calibration

1) Purpose

The purpose of this SOP is to outline the procedures for the calibration of equipment used in the pharmaceutical industry to ensure accuracy and compliance with regulatory standards.

2) Scope

This SOP applies to all measurement and testing equipment used in the pharmaceutical manufacturing process that requires calibration.

3) Responsibilities

The Quality Control and Maintenance Departments are responsible for implementing and adhering to this SOP. All relevant personnel must be trained on the procedures outlined in this document.

4) Procedure

1. Identification of Calibration Requirements
   1. Identify all equipment that requires calibration based on manufacturer recommendations and regulatory standards.
   2. Maintain a calibration schedule that includes all identified equipment.
2. Preparation for Calibration
   1. Gather all necessary tools, standards, and documentation required for calibration.
   2. Ensure the calibration environment is suitable and free from factors that could affect accuracy.
3. Execution of Calibration
   1. Perform calibration according to manufacturer instructions and industry standards.
   2. Record calibration results, including any adjustments made to the equipment.
   3. Label equipment with calibration status and next calibration date.
4. Post-Calibration Activities
   1. Review calibration records to ensure accuracy and completeness.
   2. Update the calibration schedule and documentation as necessary.

5) Abbreviations, if any

None

6) Documents, if any

Calibration Logbooks, Equipment Manuals, Calibration Certificates

7) Reference, if any

Relevant regulatory guidelines such as FDA, EMA, and WHO GMP requirements.

8) SOP Version

Version 1.0